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Oral mucositis (OM) is a major source of morbidity in patients undergoing hematopoietic cell transplantation (HCT). N-acetyl cysteine (NAC) is an antioxidant, widely used as mucolytic agent or antidote of acetaminophen overdose hepatotoxicity. we intend to explore the safety and efficacy of NAC in the prevention of OM after high-dose chemotherapy and autologous HCT in a phase III, randomized, open label and multi-center study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N acetyl cysteine | Experimental | NAC dissolved in water at a dose of 600 mg three times per day from day of transplant until neutrophil engraftment, or upon resolution of OM, whichever appears later. |
|
| Control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N acetyl cysteine | Drug | N acetyl cysteine dissolved in water at a dose of 600 mg three times daily from day of transplant until neutrophil engraftment, or upon resolution of OM, whichever appears later. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with grade 3-4 OM | Proportion of patients with grade 3-4 OM | day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with grade 1-4 OM | Proportion of patients with grade 1-4 OM | 14 days |
| Time from transplantation to first hospital discharge | Time from transplantation to first hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
• Known sensitivity to NAC
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moshe Yeshurun, MD | Contact | 0526015543 | moshe.yeshurun@gmail.com |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Phase III, randomized, open label and multi-center study.
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| 30 days |
| Non-relapse mortality | Non-relapse mortality | day 50 |
| D009057 |
| Stomatognathic Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |